Browse Device Recalls
1,361 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,361 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 1,361 FDA device recalls in NY.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 3, 2016 | dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Sea... | Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in ... | Class II | Dynarex Corporation |
| Mar 3, 2016 | Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38 | The seal between the balloon and the housing may leak. | Class II | Circulatory Technology Inc |
| Mar 2, 2016 | IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK... | Possible presence of foreign material (rust). | Class II | CMP Industries, Llc |
| Feb 18, 2016 | 1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique ... | When testing was conducted using certain lots, VITROS¿ Systems generated results within the measu... | Class II | Ortho-Clinical Diagnostics |
| Feb 17, 2016 | EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum c... | Tip crutch failure involving the bottom of the metal portion which comes in contact with ground | Class II | Medical Depot Inc. |
| Feb 17, 2016 | Aluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair... | Tip crutch failure involving the bottom of the metal portion which comes in contact with ground | Class II | Medical Depot Inc. |
| Feb 17, 2016 | Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult,... | Tip crutch failure involving the bottom of the metal portion which comes in contact with ground | Class II | Medical Depot Inc. |
| Feb 17, 2016 | Universal aluminum crutch, 1 pair per case Aid the user in walking while r... | Tip crutch failure involving the bottom of the metal portion which comes in contact with ground | Class II | Medical Depot Inc. |
| Feb 17, 2016 | Direct Supply aluminum crutch, adult, 1 pair per case Aid the user in walk... | Tip crutch failure involving the bottom of the metal portion which comes in contact with ground | Class II | Medical Depot Inc. |
| Feb 17, 2016 | Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult,... | Tip crutch failure involving the bottom of the metal portion which comes in contact with ground | Class II | Medical Depot Inc. |
| Feb 16, 2016 | VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & ... | The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situ... | Class II | Ortho-Clinical Diagnostics |
| Feb 12, 2016 | Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and He... | Complaints were received claiming the material failed to polymerize under the curing light. Afte... | Class II | Ivoclar Vivadent, Inc. |
| Jan 14, 2016 | BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in v... | False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 14, 2016 | BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for i... | False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 21, 2015 | Hip Preservation System Signature Series PreBent Burs under the following lab... | Metal shavings released from burs during use are due to contact between the bur and the hood of t... | Class II | ConMed Corporation |
| Dec 21, 2015 | VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifie... | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chem... | Class II | Ortho-Clinical Diagnostics |
| Dec 21, 2015 | VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 1... | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chem... | Class II | Ortho-Clinical Diagnostics |
| Dec 21, 2015 | VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier... | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chem... | Class II | Ortho-Clinical Diagnostics |
| Dec 21, 2015 | VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identif... | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chem... | Class II | Ortho-Clinical Diagnostics |
| Dec 21, 2015 | VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifie... | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chem... | Class II | Ortho-Clinical Diagnostics |
| Nov 19, 2015 | Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Num... | Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves wh... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 5, 2015 | Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 ... | Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiec... | Class II | ConMed Corporation |
| Nov 3, 2015 | NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 6523002... | Procedure Products initiated the recall due to the inner lumen of the needles not meeting the int... | Class II | AngioDynamics Inc. |
| Nov 3, 2015 | VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifie... | Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reage... | Class II | Ortho-Clinical Diagnostics |
| Nov 3, 2015 | VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifie... | Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reage... | Class II | Ortho-Clinical Diagnostics |
| Nov 3, 2015 | VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifie... | Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reage... | Class II | Ortho-Clinical Diagnostics |
| Nov 3, 2015 | NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No.... | Procedure Products initiated the recall due to the inner lumen of the needles not meeting the int... | Class II | AngioDynamics Inc. |
| Nov 3, 2015 | NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601... | Procedure Products initiated the recall due to the inner lumen of the needles not meeting the int... | Class II | AngioDynamics Inc. |
| Nov 3, 2015 | NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 6... | Procedure Products initiated the recall due to the inner lumen of the needles not meeting the int... | Class II | AngioDynamics Inc. |
| Nov 3, 2015 | VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identif... | Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reage... | Class II | Ortho-Clinical Diagnostics |
| Oct 7, 2015 | ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical... | Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 2, 2015 | Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting S... | The firm became aware that the KleenSpec¿ 788 Corded Illuminator has the potential to be incorrec... | Class II | Welch Allyn Inc |
| Sep 28, 2015 | VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 85... | The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes ... | Class III | Ortho-Clinical Diagnostics |
| Sep 14, 2015 | CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Pr... | CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels wh... | Class III | Biochemical Diagnostics Inc |
| Sep 10, 2015 | VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique D... | Software Anomaly during ADD Installation on VITROS 5,1 FS Chemistry Systems using Software Versio... | Class II | Ortho-Clinical Diagnostics |
| Sep 3, 2015 | BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biot... | The firm determined that 25 lots had been manufactured with a minor surface defect occurring in t... | Class II | Bausch & Lomb Inc Irb |
| Aug 28, 2015 | ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 1072303... | ISE module may produce discrepant, unflagged results for Sodium, Potassium or Chloride when the r... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 7, 2015 | CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a per... | Software defect that impacts image alignment when using the automatic stitching option for long l... | Class II | Carestream Health Inc |
| Jul 27, 2015 | Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to m... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to meas... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to mea... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to ... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to m... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to me... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to ... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to me... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to mea... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to me... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 9, 2015 | IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 6... | Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restoration... | Class II | Ivoclar Vivadent, Inc. |
| Jun 30, 2015 | VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique D... | Software anomaly may occur during the installation of an Assay Data Diskette (ADD) using Software... | Class II | Ortho-Clinical Diagnostics |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.